CurrentmhnPolicy CP.PHAR.333

Avelumab (Bavencio) Clinical Policy

Defines medical necessity criteria, indications (FDA and NCCN-recommended/off-label), dosing limits, prior authorization/documentation requirements, approval durations by line of business, excluded indications, and HCPCS coding implications for avelumab (Bavencio). Applies to commercial, HIM, and Medicaid lines of business.

Policy Summary

Payermhn

PolicyAvelumab (Bavencio) Clinical Policy

Policy CodePolicy CP.PHAR.333

Change TypePeriodic annual reviews; criteria revisions (revised)

Effective DateMay 1, 2017

Next Review Date

Key ActionProvider must submit documentation (office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.

POLICY UPDATE CHANGES

1Q 2025 annual review: added criteria for off-label use for thymic carcinoma and extranodal NK/T-cell lymphomas; for off-label salivary gland tumors removed requirement for combination use with Inlyta; references reviewed and updated.

1Q 2024 annual review: added coverage criteria for salivary gland tumors (category 2B recommendation).

1Q 2023 annual review: added recurrent MCC as a covered indication; added requirement for gestational trophoblastic neoplasia to have high-risk disease or recurrent/progressive disease after platinum regimen; added RCC clear cell histology requirement.

1Q 2022 annual review: required single-agent therapy for urothelial carcinoma per NCCN and added endometrial carcinoma indication per NCCN.

1Q 2021 annual review: for UC, recurrent disease added per NCCN and platinum-based chemotherapy history requirement added; gestational trophoblastic neoplasia off-label use added.

5FDA-approved indications listed

5NCCN off-label indications included

800 mgMaximum dose per dosing interval

Coverage Summary & Scope

This policy (CP.PHAR.333) is CURRENT and applies to Commercial, HIM, and Medicaid lines of business. It defines medical necessity criteria for avelumab (Bavencio), including FDA-approved indications and NCCN-recommended off-label uses, dose limits, prior authorization and documentation requirements, and approval durations by line of business. The policy is effective as of 05.01.17 and was last reviewed on 02.25. It incorporates FDA labeling (Bavencio Prescribing Information) and NCCN recommendations into the coverage criteria.

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Key thresholds and stats

Maximum dose800 mg every 2 weeks (4 vials)

Minimum age — Merkel cell carcinoma (MCC)≥ 12 years

Minimum age — Other indications≥ 18 years

Minimum prior exposure — Gestational trophoblastic neoplasiaFailure of ≥ 2 systemic chemotherapeutic agents

Key HCPCS codeJ9023 (Injection, avelumab, 10 mg)

I. Initial Therapy Criteria

I. Initial Approval Criteria

It is medically necessary when the following criteria are met:

Indication groups

A. Merkel Cell Carcinoma
- Diagnosis of metastatic or recurrent MCC
- Prescribed by or in consultation with an oncologist
- Age ≥ 12 years≥ 12 years
- Dose requirement (one of)

II. Continued Therapy Criteria

II. Continued Therapy (All Indications in Section I)

Criteria to approve continuation:

A. All Indications in Section I (must meet all)

Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Bavencio for a covered indication and has received this medication for at least 30 days≥ 30 days
Member is responding positively to therapy
Dose increase (one of)
- New dose does not exceed 800 mg (4 vials) every two weeks≤ 800 mg every 2 weeks

Provider Actions & Prior Authorization

Prior Authorization

Prior authorization required

Requests require prior authorization and must meet the listed diagnosis-specific criteria; prior authorization may be required for concomitant Inlyta (axitinib).

Prior authorization may be required for Inlyta (axitinib) when used in combination.

Documentation Required

Submit supporting documentation

Provider must submit office chart notes, lab results, or other clinical information supporting that the member has met all approval criteria.

Office chart notes
Laboratory results
Other clinical information (e.g., imaging, pathology reports)

Applicable Codes

HCPCS codes (informational)HCPCS

J9023

Injection, avelumab, 10 mg

HCPCS code J9023 (Injection, avelumab, 10 mg) is the key billing code referenced. Because product vials are 200 mg each, the policy dose limit of 800 mg = 4 vials every two weeks affects dosing and vial/quantity calculations for claims and prior authorization requests.

Clinical Evidence & References

Evidence:

• Prescribing Information: Bavencio Prescribing Information, EMD Serono; October 2024.

• NCCN references: Multiple NCCN compendium/guidelines referenced (MCC, Bladder, Kidney, Gestational Trophoblastic Neoplasia, Uterine, Head and Neck, T-cell, Thymic, etc.) accessed Dec 2, 2024.

This policy incorporates FDA labeling and NCCN recommendations into the coverage criteria.

Background

Background: Avelumab (Bavencio) is a PD-L1 blocking antibody. The FDA-approved indications include metastatic Merkel cell carcinoma (adults and pediatric patients ≥ 12 years), maintenance and treatment settings for locally advanced or metastatic urothelial carcinoma, and first-line treatment of advanced renal cell carcinoma in combination with axitinib. The policy includes line-of-business specific approval durations.

Quick approval durations & ages

Approval duration — Medicaid / HIM6 months (initial); 12 months for continuation across indications per policy

Approval duration — Commercial6 months or to member renewal date (initial); continuation: 6 months or to renewal date

Age thresholds (quick reference)MCC: ≥ 12 years; All other listed indications: ≥ 18 years

Definitions

Definitions / Glossary:

MCC: Merkel cell carcinoma — neuroendocrine skin cancer (term as used in this policy).

UC: Urothelial carcinoma — bladder/urothelial cancer (term as used in this policy).

RCC: Renal cell carcinoma — kidney cancer (term as used in this policy).

NCCN: National Comprehensive Cancer Network — organization providing clinical practice guidelines and compendia referenced by this policy.

dMMR: deficient mismatch repair — biomarker criteria referenced for certain indications (e.g., endometrial cancer).

MSI-H: microsatellite instability-high — biomarker criteria referenced for certain indications (e.g., endometrial cancer).

Revision History

02.25 / 12.02.25P&T ApprovalLatest

02.24 / 11.28.23P&T Approval

1Q 2024 annual review: added coverage criteria for salivary gland tumors (category 2B recommendation); references reviewed and updated.

02.23 / 11.22.22P&T Approval

Policy Summary

Payermhn

PolicyAvelumab (Bavencio) Clinical Policy

Policy CodePolicy CP.PHAR.333

Change TypePeriodic annual reviews; criteria revisions (revised)

Effective DateMay 1, 2017

Next Review Date

Key ActionProvider must submit documentation (office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.

On This Page

Dose does not exceed 800 mg (4 vials) every two weeks≤ 800 mg every 2 weeks

Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence)

Prescribed regimen must be FDA-approved or recommended by NCCN

B. Urothelial Carcinoma

Diagnosis of recurrent, locally advanced, or metastatic UC
Prescribed by or in consultation with an oncologist
Age ≥ 18 years≥ 18 years
Member has received platinum-based chemotherapy (e.g., cisplatin, carboplatin)
Prescribed as a single agent
Dose requirement (one of)
- Dose does not exceed 800 mg (4 vials) every two weeks≤ 800 mg every 2 weeks
- Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence)
Prescribed regimen must be FDA-approved or recommended by NCCN

C. Renal Cell Carcinoma

Diagnosis of advanced RCC (e.g., relapse, stage IV disease) with clear cell histology
Prescribed by or in consultation with an oncologist
Age ≥ 18 years≥ 18 years
Prescribed as first-line therapy in combination with Inlyta (axitinib); prior authorization may be required for Inlyta
Dose requirement (one of)
- Dose does not exceed 800 mg (4 vials) every two weeks≤ 800 mg every 2 weeks
- Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence)
Prescribed regimen must be FDA-approved or recommended by NCCN

D. Other NCCN Recommended Uses (off-label)

Allowed diagnoses (one of)
- Gestational trophoblastic neoplasia
- Endometrial carcinoma
- Salivary gland tumors
- Thymic carcinoma
- Extranodal NK/T-cell lymphomas
Prescribed by or in consultation with an oncologist
Diagnosis-specific requirements (may apply depending on diagnosis)
- For gestational trophoblastic neoplasia (one of)
  - Prescribed as a single agent following failure of ≥ 2 systemic chemotherapeutic agentsFailure of ≥ 2 systemic agents
  - Member has high-risk disease
  - Member has recurrent or progressive intermediate trophoblastic tumor (placental site or epithelioid) following treatment with a platinum-based regimen
- For endometrial carcinoma (both)
  - Prescribed as a single agent second-line or subsequent treatment
  - Disease is recurrent or metastatic for MSI-H or dMMR tumors
Dose requirement (one of)
- Dose does not exceed 800 mg (4 vials) every two weeks≤ 800 mg every 2 weeks
- Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence)
Prescribed regimen must be FDA-approved or recommended by NCCN

New dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence)

Prescribed regimen must be FDA-approved or recommended by NCCN

II.B Other diagnoses/indications (continuation/initial guidance)

If use is not listed or recent label change:

If drug had a label change within last 6 months not reflected in policy, refer to formulary/no coverage/non-formulary policies as specified by line of businesswithin last 6 months
See specified policies (CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16)
If requested use is not specifically listed under section III and prior criterion does not apply, refer to off-label use policy for relevant line of business
See off-label policies CP.CPA.09, HIM.PA.154, CP.PMN.53

III. Diagnoses/Indications for which coverage is NOT authorized

Non-FDA approved indications not addressed in this policy are not authorized unless there is sufficient documentation of efficacy and safety per the specified off-label use policies or evidence of coverage documents
See CP.CPA.09, HIM.PA.154, CP.PMN.53

Billing Rule

Dose limit enforcement

Dose requests should not exceed 800 mg (4 vials) every two weeks unless supported by practice guidelines or peer-reviewed literature; prescriber must submit supporting evidence for doses above this limit.

Affected code: J9023

Documentation Required

Continuation evidence

For continuation, documentation must show the member has received Bavencio for at least 30 days and is responding positively to therapy.

02.22 / 11.11.21P&T Approval

1Q 2022 annual review: required single-agent therapy for urothelial carcinoma per NCCN and added endometrial carcinoma indication per NCCN; references reviewed and updated.

02.21 / 11.06.20P&T Approval

1Q 2021 annual review: for UC, recurrent disease added per NCCN and platinum-based chemotherapy history added; gestational trophoblastic neoplasia off-label use added; references reviewed and updated.

For salivary gland tumors (one of)

Recurrent adenoid cystic carcinoma with distant metastases in patients with performance status 0-3
Unresectable locoregional recurrence or second primary with prior radiation therapy

For thymic carcinoma

Use in combination with Inlyta for locally advanced or metastatic disease following treatment or intolerability to a first-line combination therapy regimen
Prior authorization may be required for Inlyta

For extranodal NK/T-cell lymphomas

Prescribed for relapsed/refractory disease following additional therapy with an alternative combination chemotherapy regimen not previously used
A clinical trial is unavailable